MAUDE Adverse Event Report: B.BRAUN MEDICAL SAS CELSITE; ACCESS PORT SYSTEM

Model Number 4430893

Device Problem Fracture (1260)

Patient Problems Edema (1820); Pain (1994)

Event Date 04/14/2020

Event Type  Injury  

Manufacturer Narrative

Product reference (b)(4) is not cleared for sales in the usa, but its catheter is similar to the product reference (b)(4) cleared under #510k130576.Batch history review: the batch number of the involved device is unknown.No batch history review can be performed.Investigation results: despite our requests, we did not received the complaint sample nor the x-ray pictures for investigation.We have received two pictures, showing a catheter rupture at 11 cm from the connection to the port.But these pictures are inconclusive concerning the defect root cause.Conclusion: without the complaint sample or the x-ray pictures for investigation, no thorough investigation is possible and we cannot conclude on the real cause of the incident.If new element become available in the future, we will re-open this complaint.Catheter rupture is a known complication of the access port implantation that could have different root causes.This is a rare incident (<0.01%).No corrective action is currently envisaged.

Event Description

"patient (b)(6) years old with diagnosis acute lymphoblastic leukemia, whom implanted celsite for chemioterapy on march 31.On april 14 according health records, nurse verified permeability whit sterile whater and relise leakage in the site of the punction, whit edema.Patient refered neck pain.Fuoroscopy was performed for the bad funtion of the device, and it relise the catheter is broken upon entry of the subclavian.Patient was transferred to surgery for remove catheter and implant a new one.Patient was transferred to critical care for monitorization".

• Brand Name: CELSITE
• Type of Device: ACCESS PORT SYSTEM
• Manufacturer (Section D): B.BRAUN MEDICAL SAS; 26 rue armengaud; saint cloud, 92210 ; FR 92210
• Manufacturer (Section G): B.BRAUN MEDICAL SAS FRANCE; 30 avenue des temps modernes; chasseneuil du poitou, 86360 ; FR 86360
• Manufacturer Contact: catherine boismenu ; 30 avenue des temps modernes; chasseneuil du poitou, 86360 ; FR 86360
• MDR Report Key: 10319716
• MDR Text Key: 200255997
• Report Number: 9612452-2020-00025
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4430893
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR